Epidemiological Study on the Relationship Between Respiratory Health and Air Pollution From Industrial Sources

The ELISABET STUDY is across sectional Survey on a representative sample of two urban area conduct on a representative sample. The main objective of the project is to compare the prevalence of the obstructive ventilatory disorders (OVD) in the Urban Community of Dunkirk touched by the industrial pollution in relation to the one recovered in the Urban Community of Lille (CUDL) less industrialized.

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Key information

Conditions

Airway Obstruction Cardiovascular Diseases Chronic Disease Diabetes Mellitus Disease Attributes Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Lipid Metabolism Disorders Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Vascular Diseases

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Observational

About this study

Airflow obstruction include Pulmonary Disease, Chronic Obstruction and asthma. Identification of Airflow obstruction is through Functional Tests Lung. In the 1950s, high pollution levels were associated with increased mortality. Despite a reduction of air pollution, it has been established that pollution peaks have short-term effects on acute respiratory episodes. The Urban Community of Dunkirk (CUD) focuses many large pollutant emitters. The long term effects of industrial pollution on TVO are unknown.

The main objective of the project is to compare the prevalence of Airflow obstruction in the Urban Community of Dunkirk affected by industrial pollution compared to that found in the Urban Community of Lille (CUDL) less industrialized. Secondary objectives are: 1) To assess the relationship between air pollution from industrial and biological markers, particularly the plasma concentrations of heavy metals 2) To assess the prevalence of TVO general population in French populations 3) Establish a baseline epidemiological and biological bank.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

had lived for at least 5 years in the same city or its surrounding urban area (either Lille or Dunkirk) in the northern of France
Agreed to participate and signed contentment

Exclusion criteria

The detainees
People under legal protection
Individuals unable to consent

Treatment and study plan

heteroevaluation scale by a nurse or doctor

Other

Primary outcomes

airway obstruction

Time frame: during a the single visit scheduled (less than 3 hours in the morning)

Forced expiratory volume per second (FEV1) to forced vital capacity (FVC) ratio below 0.7. mesured by standardized spirometry

Spirometry testing was performed mostly at home using Micro 6000 spirometers (Medisoft; Sorinnes, Belgium), according to the 2005 ATS/ERS guidelines. The spirometers were calibrated weekly. No bronchodilators were administered. For each participant, the spirometry test was repeated (up to seven times) until three acceptable, reproducible flow-volume loops were obtained, following the same guidelines. The greatest reproducible values of FEV1 and FVC were selected for the statistical analysis (regardless of whether these two values came from separate curves or from the same curve). All spirometry data were validated by an experienced, specialist physician.

Secondary outcomes

hypertension

Time frame: during a the single visit scheduled (less than 3 hours in the morning)

Hypertension was defined as ongoing antihypertensive treatment, an Systolic blood pressure >=140 mmHg or a Diastolic Blood pressure >=90 mmHg
dyslipidemia

Time frame: during a the single visit scheduled (less than 3 hours in the morning)

Dyslipidemia was defined as ongoing cholesterol-lowering treatment or one or more abnormal fasting blood lipid values (total cholesterol 2.4 g/L, LDLcholesterol>=1.6 g/L, HDLcholesterol <0.4 g/L or blood triglycerides >=2 g/L)
diabetes mellitus

Time frame: during a the single visit scheduled (less than 3 hours in the morning)

Diabetes mellitus was defined as ongoing antidiabetes treatment (oral medication or insulin) or a fasting blood glucose (FBG) level >=1.26 g/L

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

ELISABET : Enquête LIttoral Souffle Air Biologie Environnement

Acronym: ELISABET

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2014
First posted: Jul 7, 2015
Registry last updated: Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed